Cell mediated tumor immunity has been demonstrated in experiments with transplanted tumors in mice and rats. For example, Halliday et al. Int. J. Cancer, Vol. 9, pages 477-483 (1972) established a simple assay of cell mediated immunity called Leukocyte Adherence Inhibition. This assay was based on the findings that the adherence of peritoneal leukocytes to glass is specifically inhibited by the addition of tumor extracts if the peritoneal leukocytes are obtained from mice which have been presensitized against the specific tumor. Holan et al., Cellular Immunology, Vol. 13, pages 107-116 (1974), using transplanted tumors in rats, mice and guinea pigs also demonstrated the same phenomenon with macrophage cells. There has been much research in attempts to utilize immunological principles for the detection and possible cure for various human cancers. While success has been met in animal models having transplanted tumors, immunological methods developed for the detection of breast cancers have not been successful for mass screening. While it has been generally known that an immunological defense mechanism exists in the early stages of malignant diseases, while such defense mechanism has been demonstrated with breast cancer in humans with macrophage migration inhibition and by interdermal injections of breast antigens which show a delayed hypersensitivity response, such assays are unsuitable for large scale screening.
In recent years a great many studies have been made in the medical diagnostics field to achieve detection of breast cancer in humans, however, no blood tests have been developed which can be used in mass screening programs for breast cancer detection. The diagnostic tests available to the clinician are based on visual observation of cells, x-rays, or thermography. These tests, however, are time consuming, complex and subjective. Ideally, a desirable test for human breast carcinoma would be a blood test which is simple, specific and reproducible and which detects the disease at a sufficiently early stage so that the disease is still curable.